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  1. Home
  2. /Settlement News
  3. /Recall Watch

Accord Recalled Levothyroxine for Low Potency a Fifth Time in 16 Months — 12 Strengths and 53 Lots Posted September 2, 2026, With No Bottle Count. There Is No Settlement and No Claim Form.

Does this affect you?

AI Legal Assistant · free · answers in seconds · general information, not legal advice

Accord Healthcare, Inc. recall of levothyroxine sodium tablets in 12 strengths (25 to 300 mcg), made by Intas Pharmaceuticals in India: FDA recall numbers D-0775-2026 through D-0786-2026, Class II, reason “Subpotent Drug,” initiated August 6, 2026, classified August 21, 2026, published in the FDA Enforcement Report of September 2, 2026. 53 lots with expiration dates from August 31, 2026 to January 31, 2027; no bottle count was given. It is Accord’s fifth low-potency levothyroxine round since April 10, 2025; the four earlier rounds that list quantities total 255,131 bottles by our count. Also in 2026: Major Pharmaceuticals (Class II, July 17, 2026), Macleods, Alvogen, and a Class I superpotency recall of Vitruvias Thyroid Tablets (1,955 bottles, September 23, 2026). There is no lawsuit, settlement or claim form.

By Settlement Insight Data Desk · October 20, 2026

Accord Recalled Levothyroxine for Low Potency a Fifth Time in 16 Months — 12 Strengths and 53 Lots Posted September 2, 2026, With No Bottle Count. There Is No Settlement and No Claim Form. — key figures at a glance

Is levothyroxine being recalled? Yes — check the lot, not the drug name

Yes. On September 2, 2026, the FDA’s weekly Enforcement Report listed a new Class II recall by Accord Healthcare, Inc. of Raleigh, North Carolina: levothyroxine sodium tablets in 12 strengths — 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200 and 300 mcg — made for Accord by Intas Pharmaceuticals in Dehradun, India. The reason given in every one of the 12 entries is two words: “Subpotent Drug.” In plain terms, testing found tablets with less thyroid hormone than the label promises. Accord started the recall on August 6, 2026, by letter to its customers; the FDA classified it on August 21, 2026. Distribution was “Nationwide within the United States.”

The recall is defined by lot number, not by the drug. Across the 12 entries we counted 53 lot numbers, all beginning with “D24” or “D25” (for example D2402430 or D2500180), with expiration dates from August 31, 2026 to January 31, 2027. The bottles are 90-count and 1000-count stock bottles with NDC codes starting 16729. Most patients never see those bottles: a pharmacy pours tablets from a 1000-count bottle into an orange vial with its own label. That is why the useful first step is a phone call to the pharmacy that filled the prescription, asking whether your last fill came from an Accord lot on the September 2 list. AARP’s guidance on a separate levothyroxine recall this summer says the same: “If your medication is packaged in a pharmacy-labeled container and the original lot information is not visible, contact your pharmacist or health care provider.”

The FDA entries give no bottle count — the quantity field reads “N/A” in all 12 — and we found no Accord press release or patient letter. As of the openFDA data update of October 7, 2026, all 12 entries were listed as “Ongoing.” Several lots had already passed their expiration date when the recall was posted, which tells you how slowly these notices reach the public.

Accord’s fifth round in 16 months — and three other levothyroxine recalls in 2026

What makes this recall worth a closer look is the pattern. FDA enforcement data show Accord has now pulled levothyroxine for low potency in five separate rounds, initiated on April 10, 2025; June 20, 2025; September 16, 2025; June 8, 2026; and August 6, 2026 — 16 months from the first to the fifth. The four rounds that list quantities add up, by our count, to 255,131 bottles: 33,629 in April 2025, 160,638 in June 2025 (the round widely reported last summer as “more than 160,000 bottles”), 54,432 in September 2025 (an 88 mcg lot whose “assay content was observed below the approved specification range” during long-term stability testing), and 6,432 bottles of the 300 mcg strength in June 2026. The fifth round is the broadest by strength count, and the only one with no number.

Accord is not alone. The 2026 Enforcement Reports contain 27 levothyroxine sodium entries from four companies:

  • Major Pharmaceuticals — unit-dose cartons and blister packs, strengths 25 to 150 mcg, initiated July 13, 2026, classified Class II on July 17, 2026, also “Subpotent Drug.” AARP reports that some packs were distributed by Cardinal Health and that expiration dates run from July 2026 to January 2027.
  • Macleods — 1,315 bottles of 150 mcg, subpotent, initiated February 26, 2026.
  • Alvogen — Thyro-Tabs 150 mcg, a product mix-up, listed January 21, 2026.

A different thyroid drug carries the most serious class. On September 23, 2026, the FDA listed a Class I recall by Vitruvias Therapeutics of Auburn, Alabama: Thyroid Tablets, USP, 1/2 grain (30 mg), each with levothyroxine 19 mcg and liothyronine 4.5 mcg — 1,955 bottles of lot 504950, expiration September 30, 2026. Here the problem runs the other way: “Superpotent Drug,” meaning too much hormone.

What a pharmaceutical recall is — and what the classes mean for you

What is a product recall in the pharmaceutical industry? The FDA’s own definition: “A recall is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk.” The company acts; the FDA assigns a class and publishes the entry. The classes, in the agency’s words:

  • Class I — “a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
  • Class II — the Accord and Major levothyroxine recalls: use “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
  • Class III — “not likely to cause adverse health consequences.”

Pharmaceutical companies recall drugs constantly, mostly without a press release. In the six weekly Enforcement Reports from September 2 to October 7, 2026, we counted 93 drug recall entries from 41 companies: 8 Class I, 76 Class II, 7 Class III and 2 not yet classified. Many are hospital IV bags and injectables, but several are pharmacy-shelf drugs: Teva recalled 175,392 bottles of trazodone 50 mg (lot 1394026) for “Presence of Foreign Tablets/Capsules,” and Mylan recalled 47,662 bottles of prasugrel 10 mg for failed dissolution. A recent drug recall announcement on the FDA’s recall page is dated October 14, 2026: Par Health is recalling 22 lots of argatroban injection 250 mg/2.5 mL to the hospital/user level over particulate matter. Over a longer view, the FDA says more than 83,000 FDA-regulated products were recalled between 2014 and 2024.

Why has atorvastatin been recalled? The atorvastatin recall that still circulates in search results is Ascend Laboratories’ Class II recall of atorvastatin calcium tablets in 10, 20, 40 and 80 mg, initiated September 19, 2025, for “Failed Dissolution Specifications” — the tablets may not dissolve properly in the body. The 10 mg entry lists 141,984 bottles. Earlier, Biocon recalled 2,184 bottles of 40 mg in March 2025 for the same reason. We found no atorvastatin entry in the FDA reports published in 2026 through October 7.

Was my medication recalled? What to do, step by step

  1. Find the lot. If you have the manufacturer’s bottle, the lot and expiration date are printed on the label. If you have a pharmacy vial, ask the pharmacy which manufacturer and lot it filled from — they keep that record.
  2. Compare it with the FDA entry. The FDA says it publishes “a descriptive listing of each new recall” in its Enforcement Report; the lot lists for the Accord round are summarized in our data box below.
  3. Do not decide on your own to stop a prescription. AARP, citing the FDA, says patients can generally continue using a medicine under a Class II recall unless the recalling company or the FDA directs otherwise, and a thyroid prescription is a daily hormone replacement. If you believe your levothyroxine is part of a recall, contact your pharmacist or health care provider; that is the step AARP recommends for the levothyroxine recalls.
  4. Return or exchange. The FDA notes that “often, recalled products can be returned to the store where they were purchased.” No official source we read sets out whether pharmacies replace recalled levothyroxine free of charge; ask before you pay for a new fill.
  5. Report problems. If you had symptoms you think are linked to a recalled lot, tell your doctor and report it to the FDA’s MedWatch program, which the agency says takes reports online, by phone or by mail.

Is there money? No settlement, no claim form — and how to spot a fake

A recall is not a settlement. Nobody gets paid automatically because a lot was recalled, and as of October 20, 2026 we found no class action, settlement, claim form or court-approved fund tied to the Accord, Major, Macleods or Vitruvias thyroid recalls. A search of the federal court records we track turned up two cases naming Accord Healthcare, both brought by other drug companies, and none mentioning levothyroxine. Recalls do sometimes lead to lawsuits: we covered a proposed class action filed after Glenmark’s carvedilol recalls (linked below). But until a court approves a settlement, there is nothing to file.

That makes any message offering a “levothyroxine recall payment” or asking for a fee or your bank details to “join” a recall settlement suspect. The real notices in these recalls went from the company to its customers by letter, and the FDA publishes the details for free. A genuine class-action settlement has a court case number and is approved by a judge before anyone can claim.

Searching for a pharmaceutical companies recall list? The authoritative list is the FDA’s weekly Enforcement Report and its Drug Recalls page; the Accord levothyroxine round appears in the first and not on the second.

The Data Behind This Story

Recall
Accord Healthcare levothyroxine sodium tablets, FDA recall numbers D-0775-2026 to D-0786-2026, Class II
Reason
“Subpotent Drug” — tablets below the approved potency
Dates
Initiated August 6, 2026 · classified August 21, 2026 · FDA Enforcement Report September 2, 2026 · status “Ongoing” at the October 7, 2026 data update
Strengths
25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200 and 300 mcg; 90-count and 1000-count bottles; NDC codes beginning 16729
Lots
53 lot numbers beginning D24 or D25; expiration dates August 31, 2026 to January 31, 2027; quantity not published
Accord pattern
Fifth low-potency levothyroxine round since April 10, 2025; earlier rounds 33,629 + 160,638 + 54,432 + 6,432 = 255,131 bottles (our sum)
Other 2026 levothyroxine recalls
Major Pharmaceuticals (25 to 150 mcg, Class II July 17, 2026) · Macleods (150 mcg, 1,315 bottles) · Alvogen Thyro-Tabs (mix-up) — 27 entries from four companies
Class I thyroid recall
Vitruvias Thyroid Tablets 1/2 grain, lot 504950, 1,955 bottles, superpotent, listed September 23, 2026
All drug recalls, Sept 2–Oct 7, 2026
93 entries from 41 companies: 8 Class I, 76 Class II, 7 Class III, 2 unclassified (our tally of FDA data)
Atorvastatin
Ascend Laboratories, 10/20/40/80 mg, failed dissolution, initiated September 19, 2025; 141,984 bottles on the 10 mg entry; no 2026 entry
Money
No settlement, no claim form, no class action found as of October 20, 2026
What to do
Ask your pharmacy which lot it filled; don’t stop a prescription without your pharmacist or doctor; report problems to FDA MedWatch
  • Source: openFDA Drug Enforcement API, report dates September 1 to October 20, 2026 (data last updated October 7, 2026), read October 20, 2026: the 12 Accord levothyroxine entries D-0775-2026 to D-0786-2026 (strengths, lots, expiration dates, initiation, classification and report dates, status, distribution, letter notification), the Vitruvias Class I entry D-0866-2026, Teva trazodone D-0834-2026, Mylan prasugrel D-0839-2026, and the tally of 93 entries by class and firm
  • Source: openFDA Drug Enforcement API, all levothyroxine entries with 2025 and 2026 report dates, read October 20, 2026: Accord’s earlier rounds (D-0394 to D-0397-2025, D-0518 to D-0524-2025, D-0006-2026, D-0656-2026) with quantities and initiation dates; Major Pharmaceuticals D-0700 to D-0711-2026; Macleods D-0403-2026; Alvogen D-0259-2026
  • Source: openFDA Drug Enforcement API, atorvastatin entries with 2025–2026 report dates, read October 20, 2026: Ascend Laboratories D-0017 to D-0020-2026 and Biocon D-0306-2025
  • Source: FDA, Recalls Background and Definitions, read October 20, 2026: definitions of Class I, II and III recalls
  • Source: FDA, Drug Recalls page, read October 20, 2026: definition of a drug recall as a voluntary company action; latest announcement (Par Health argatroban, October 14, 2026)
  • Source: FDA press release, Par Health argatroban injection recall, October 13, 2026 (posted October 14), read October 20, 2026: 22 lots, hospital/user level, particulate matter
  • Source: FDA Consumer Update, FDA 101: Product Recalls, read October 20, 2026: 83,000 recalled products 2014–2024, Enforcement Report, return-to-store and MedWatch guidance
  • Source: AARP, levothyroxine recall article (Major Pharmaceuticals, July 2026), read October 20, 2026: Cardinal Health distribution, expiration range, advice to ask a pharmacist when the lot is not visible
  • Source: Federal docket database (CM/ECF feeds since October 10, 2026; full file as of September 30, 2026), searched October 20, 2026: no case naming levothyroxine or Major Pharmaceuticals; two cases naming Accord Healthcare brought by drug companies

Journalists: these figures are free to cite with attribution to Settlement Insight. Custom data pulls: press@settlementinsight.com.

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